We are 5 people living with MND in the United Kingdom who have been heavily involved in campaigning for improved research funds for translational research on the condition in the last few years and have extensive high-level contacts in the UK research and charity community. We are known already to some of you. Please see

https://united2endmnd.org/  &

https://darbyrimmermnd.co.uk/ for more details.

We follow research very closely and believe in “robust science” as practised by the most senior researchers in the UK and overseas. Your work on the Mirocals trial has been outstanding and we are extremely grateful to all of you involved for that.

As many of you will now know we are extremely concerned about the delay in publishing the data/paper since the announcement of “top line results” last December. This and the announcement of the contract with Iltoo has given rise to a number of very difficult questions within the UK MND community.

We have done our very best to defend the actions taken by the Consortium but the questions persist. The current “information vacuum” is being filled by speculation.

We note the MND Association’s and the Consortium’s use of the defence of “commercial confidentiality” in not being able to answer the community’s questions fully and frankly. We question this because Mirocals was funded by UK and European taxpayers and charity donors, including ourselves and fellow patients and their families. 

We acknowledge the need for pharmaceutical company involvement at the appropriate stage, but clearly your hugely important initiative was not “Pharma-led”. The most difficult questions to answer are those concerning the relationship with Iltoo and why a contract with a larger, better funded company with the rights to Proleukin was not (also) concluded.

The situation could be eased considerably if the questions below could be answered as soon as possible. It would, of course, be further eased if the scientific paper/data is released in the very near future and if Consortium members could publicly show their support for getting access to a safe formulation of Interleukin 2 to patients, wherever they may live, as quickly as possible. N.b. We believe this MUST include getting access to Proleukin, a drug available in UK hospital pharmacies now, as well as any new formulation.

As members of the Mirocals Consortium we believe you should be able to provide the answers. 

We look forward to hearing from you. 

With best wishes. Emma, David, Lee, Nicola and Stephen

Emma Moss – David Setters – Lee Millard – Nicola Waters – Stephen Darby

QUESTIONS

• Why are the full trial results not being released?  Are there contractual reasons and / or are some members of the Consortium blocking?
• Who is making money from the sale of the trial results and the creation of a new IL-2 product?  How can this happen given it was funded by taxpayers and charities?
• Why was a deal done with a company, Iltoo, that does not have a commercial product which, when created, will have to go through further trials and approval processes when an existing drug, Proleukin, is already available commercially around the world.
• Why have 2 companies using the name Iltoo been established in the UK in the first half of 2023 with the same address as a company, WGK, which has had interest in the Mirocals trial since 2015?
• Why are patients who took part in the trial not being given access to the trial drug, Proleukin, now?
• Why isn’t the Consortium supporting patients to access Proleukin now?